Evaluation of Norfloxacin in the Pediatric Field: Pediatric Study Group for Norfloxacin

Ryochi Fujii, Hidenori Meguro, Osamu Arimasu, Kouji Ushijima, Toshiaki Abe, Susumu Nakazawa, Hajime Sato, Akira Narita, Kenji Niino, Haruo Ichihashi, Hiroo Matsuda, Hiroshi Hirosawa, Shintaro Takahashi, Yasuko Ishikawa, Yoshikiyo Toyonaga, Morimasa Sugita, Keisuke Sunakawa, Hironobu Akita, Yoshitake Sato, Satoshi IwataMikio Minamitani, Kei Hachimori, Kuniyoshi Kuno, Akimasa Ogawa, Yoshikuni Nakao, Fumio Hayakawa, Yoshihiro Ando, Osamu Kito, Naoichi Iwai, Mitsunobu Miyazu, Haruhi Nakamura, Michihiro Katayama, Keiko Kasai, Minoru Sakurai, Hitoshi Kamiya, Toshiaki Ihara, Hiroshi Kawaguchi, Tadafumi Nishimura, Michio Takagi, Kazuo Tabuki, Shigeyuki Aoki, Yutaka Kobayashi, Tsunekazu Haruta, Hiroshi Matsuda, Kaichi Kida, Junichi Ishikawa, Toshihito Matsuura, Hironao Nagai, Hideo Morita, Takashi Tomoda, Kumiko Araki, Kenji Matsumoto, Noriko Zushi, Takanobu Kurashige, Yohei Nishibayashi, Kaname Okada, Shoji Kagami, Yasuhiro Kuroda, Takashige Okada, Seikyo Furukawa, Takashi Motohiro, Yasutaka Sakata, Masafumi Aramaki, Keiko Oda, Akira Kawakami, Tatsuhiko Koga, Fumio Yamashita, Syunji Karube

研究成果: Article

21 引用 (Scopus)

抄録

Norfloxacin (NFLX, AM-715), a new quinolone antibiotic agent, was evaluated clinically and bacteriologically for its efficacy and safety in pediatrics by a study group organized with pediatricians from all over the country. A summary of the results of the evaluation is as follows. 1. Incidence of NFLX-resistant strains (MIC over 12.5 μg/ml) isolated from children with various infections was 1.6% (8/512). One resistant strain was observed among 45 isolates of Staphylococcus aureus, and none among 30 isolates of Pseudomonas aeruginosa. 2. After single oral administration of 1.5~2.9, 3.0~4.8 and 5.1~6.1 mg/kg NFLX in tablet form at fasting, mean peak values of serum concentration of 0.37, 0.56, 0.92 μg/ml, T 1/2 of 2.5, 2.6, 2.6 hours and urinary recovery rates in 8 hours at 25.3, 25.3, 27.1% were observed, respectively. 3. Clinical effects were studied chiefly in intestinal and urinary tract infections. Among 317 patients from whom pathogens had been isolated, responses to the treatment were excellent in 187, good in 79, fair in 9, poor in 7, and unknown in 35 cases. The overall efficacy rate was 94.3% (266/282) and the efficacy rate for excellent responses was 70.3% (187/266). Among all the 406 patients treated, including those with undetermined pathogens, responses were excellent in 233, good in 106, fair in 11, poor in 11, and unknown in 45 cases. The overall efficacy rate was 93.9% (339/361). 4. Clinical effects of NFLX classified by diseases with identified pathogens were 81.8% (9/11) for acute pneumonia, 80.8% (21/26) for other respiratory infections, 95.8% (23/24) for bacillary dysentery, 98.6% (70/71) for Campylobacter enteritis, 100% (24/24) for Salmonella enteritis, 100% (6/6) for other acute enteritis and 98.1% (104/106) for urinary tract infections. Including other infections as high as 94.3% (266/282) of efficacy rate was obtained in total. There was no significant difference in NFLX efficacies between unidentified and identified pathogens. Thus, the total clinical efficacy rate was 93.9% (339/361). 5. The total eradication rate of 325 pathogens evaluable was 84.3%,with identical eradication rates for Gram-positive cocci (GPC) (43/51) and for Gram-negative rods (GNR) (231/274). 6. The optimal daily dose of NFLX seemed to be in a range between 6.0 and 12.0 mg/kg, and the optimal duration of treatment to be 7 days for children over 5 years old. 7. The clinical efficacy in treating P. aeruginosa infections in 12 patients was 100% (11/11) and the eradication rate was 83.3% (10/12). 8. In 59 non-responsive cases to other antimicrobials (treated over 3 days), efficacy rate was 88.9% with 58.3% of the excellent responder rate. Particularly in 13 cases treated with penicillin of cephems the overall efficacy rate was 90.9%, and the eradication rate was 93.6%. Except 1 strain of Streptococcus pneumoniae in 10 strains of GPC and 2 strains of P. aeruginosa in 37 strains of GNR, all bacteria were eradicated. 9. Adverse reactions were found in 6 (1.5%) cases of 406 patients. The reactions were all mild and could continue the administration of the drug. The joint injuries were not found in all cases nevertheless our careful observation to the joint. Laboratory examinations revealed transient and mild eosinophillia in 8 cases of 309 patients studied. And no changed was observed in serum Cathepsin D, ASPRO-GP, Al-P, urinary mucopolysiaccharide titers and electrophoretic isozyme patterns of Al-P which suggest arthropathy, during the course of NFLX therapy.

元の言語English
ページ(範囲)181-215
ページ数35
ジャーナルThe Japanese Journal of Antibiotics
43
発行部数1
DOI
出版物ステータスPublished - 1990
外部発表Yes

Fingerprint

Norfloxacin
Enteritis
Pediatrics
Pseudomonas aeruginosa
Gram-Positive Cocci
Urinary Tract Infections
Joints
Bacillary Dysentery
Pseudomonas Infections
Cathepsin D
Campylobacter
Joint Diseases
Quinolones
Streptococcus pneumoniae
Infection
Serum
Salmonella
Respiratory Tract Infections
Penicillins
Isoenzymes

ASJC Scopus subject areas

  • Medicine(all)
  • Microbiology (medical)
  • Pharmacology (medical)
  • Infectious Diseases

これを引用

Fujii, R., Meguro, H., Arimasu, O., Ushijima, K., Abe, T., Nakazawa, S., ... Karube, S. (1990). Evaluation of Norfloxacin in the Pediatric Field: Pediatric Study Group for Norfloxacin. The Japanese Journal of Antibiotics, 43(1), 181-215. https://doi.org/10.11553/antibiotics1968b.43.181

Evaluation of Norfloxacin in the Pediatric Field : Pediatric Study Group for Norfloxacin. / Fujii, Ryochi; Meguro, Hidenori; Arimasu, Osamu; Ushijima, Kouji; Abe, Toshiaki; Nakazawa, Susumu; Sato, Hajime; Narita, Akira; Niino, Kenji; Ichihashi, Haruo; Matsuda, Hiroo; Hirosawa, Hiroshi; Takahashi, Shintaro; Ishikawa, Yasuko; Toyonaga, Yoshikiyo; Sugita, Morimasa; Sunakawa, Keisuke; Akita, Hironobu; Sato, Yoshitake; Iwata, Satoshi; Minamitani, Mikio; Hachimori, Kei; Kuno, Kuniyoshi; Ogawa, Akimasa; Nakao, Yoshikuni; Hayakawa, Fumio; Ando, Yoshihiro; Kito, Osamu; Iwai, Naoichi; Miyazu, Mitsunobu; Nakamura, Haruhi; Katayama, Michihiro; Kasai, Keiko; Sakurai, Minoru; Kamiya, Hitoshi; Ihara, Toshiaki; Kawaguchi, Hiroshi; Nishimura, Tadafumi; Takagi, Michio; Tabuki, Kazuo; Aoki, Shigeyuki; Kobayashi, Yutaka; Haruta, Tsunekazu; Matsuda, Hiroshi; Kida, Kaichi; Ishikawa, Junichi; Matsuura, Toshihito; Nagai, Hironao; Morita, Hideo; Tomoda, Takashi; Araki, Kumiko; Matsumoto, Kenji; Zushi, Noriko; Kurashige, Takanobu; Nishibayashi, Yohei; Okada, Kaname; Kagami, Shoji; Kuroda, Yasuhiro; Okada, Takashige; Furukawa, Seikyo; Motohiro, Takashi; Sakata, Yasutaka; Aramaki, Masafumi; Oda, Keiko; Kawakami, Akira; Koga, Tatsuhiko; Yamashita, Fumio; Karube, Syunji.

:: The Japanese Journal of Antibiotics, 巻 43, 番号 1, 1990, p. 181-215.

研究成果: Article

Fujii, R, Meguro, H, Arimasu, O, Ushijima, K, Abe, T, Nakazawa, S, Sato, H, Narita, A, Niino, K, Ichihashi, H, Matsuda, H, Hirosawa, H, Takahashi, S, Ishikawa, Y, Toyonaga, Y, Sugita, M, Sunakawa, K, Akita, H, Sato, Y, Iwata, S, Minamitani, M, Hachimori, K, Kuno, K, Ogawa, A, Nakao, Y, Hayakawa, F, Ando, Y, Kito, O, Iwai, N, Miyazu, M, Nakamura, H, Katayama, M, Kasai, K, Sakurai, M, Kamiya, H, Ihara, T, Kawaguchi, H, Nishimura, T, Takagi, M, Tabuki, K, Aoki, S, Kobayashi, Y, Haruta, T, Matsuda, H, Kida, K, Ishikawa, J, Matsuura, T, Nagai, H, Morita, H, Tomoda, T, Araki, K, Matsumoto, K, Zushi, N, Kurashige, T, Nishibayashi, Y, Okada, K, Kagami, S, Kuroda, Y, Okada, T, Furukawa, S, Motohiro, T, Sakata, Y, Aramaki, M, Oda, K, Kawakami, A, Koga, T, Yamashita, F & Karube, S 1990, 'Evaluation of Norfloxacin in the Pediatric Field: Pediatric Study Group for Norfloxacin', The Japanese Journal of Antibiotics, 巻. 43, 番号 1, pp. 181-215. https://doi.org/10.11553/antibiotics1968b.43.181
Fujii, Ryochi ; Meguro, Hidenori ; Arimasu, Osamu ; Ushijima, Kouji ; Abe, Toshiaki ; Nakazawa, Susumu ; Sato, Hajime ; Narita, Akira ; Niino, Kenji ; Ichihashi, Haruo ; Matsuda, Hiroo ; Hirosawa, Hiroshi ; Takahashi, Shintaro ; Ishikawa, Yasuko ; Toyonaga, Yoshikiyo ; Sugita, Morimasa ; Sunakawa, Keisuke ; Akita, Hironobu ; Sato, Yoshitake ; Iwata, Satoshi ; Minamitani, Mikio ; Hachimori, Kei ; Kuno, Kuniyoshi ; Ogawa, Akimasa ; Nakao, Yoshikuni ; Hayakawa, Fumio ; Ando, Yoshihiro ; Kito, Osamu ; Iwai, Naoichi ; Miyazu, Mitsunobu ; Nakamura, Haruhi ; Katayama, Michihiro ; Kasai, Keiko ; Sakurai, Minoru ; Kamiya, Hitoshi ; Ihara, Toshiaki ; Kawaguchi, Hiroshi ; Nishimura, Tadafumi ; Takagi, Michio ; Tabuki, Kazuo ; Aoki, Shigeyuki ; Kobayashi, Yutaka ; Haruta, Tsunekazu ; Matsuda, Hiroshi ; Kida, Kaichi ; Ishikawa, Junichi ; Matsuura, Toshihito ; Nagai, Hironao ; Morita, Hideo ; Tomoda, Takashi ; Araki, Kumiko ; Matsumoto, Kenji ; Zushi, Noriko ; Kurashige, Takanobu ; Nishibayashi, Yohei ; Okada, Kaname ; Kagami, Shoji ; Kuroda, Yasuhiro ; Okada, Takashige ; Furukawa, Seikyo ; Motohiro, Takashi ; Sakata, Yasutaka ; Aramaki, Masafumi ; Oda, Keiko ; Kawakami, Akira ; Koga, Tatsuhiko ; Yamashita, Fumio ; Karube, Syunji. / Evaluation of Norfloxacin in the Pediatric Field : Pediatric Study Group for Norfloxacin. :: The Japanese Journal of Antibiotics. 1990 ; 巻 43, 番号 1. pp. 181-215.
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title = "Evaluation of Norfloxacin in the Pediatric Field: Pediatric Study Group for Norfloxacin",
abstract = "Norfloxacin (NFLX, AM-715), a new quinolone antibiotic agent, was evaluated clinically and bacteriologically for its efficacy and safety in pediatrics by a study group organized with pediatricians from all over the country. A summary of the results of the evaluation is as follows. 1. Incidence of NFLX-resistant strains (MIC over 12.5 μg/ml) isolated from children with various infections was 1.6{\%} (8/512). One resistant strain was observed among 45 isolates of Staphylococcus aureus, and none among 30 isolates of Pseudomonas aeruginosa. 2. After single oral administration of 1.5~2.9, 3.0~4.8 and 5.1~6.1 mg/kg NFLX in tablet form at fasting, mean peak values of serum concentration of 0.37, 0.56, 0.92 μg/ml, T 1/2 of 2.5, 2.6, 2.6 hours and urinary recovery rates in 8 hours at 25.3, 25.3, 27.1{\%} were observed, respectively. 3. Clinical effects were studied chiefly in intestinal and urinary tract infections. Among 317 patients from whom pathogens had been isolated, responses to the treatment were excellent in 187, good in 79, fair in 9, poor in 7, and unknown in 35 cases. The overall efficacy rate was 94.3{\%} (266/282) and the efficacy rate for excellent responses was 70.3{\%} (187/266). Among all the 406 patients treated, including those with undetermined pathogens, responses were excellent in 233, good in 106, fair in 11, poor in 11, and unknown in 45 cases. The overall efficacy rate was 93.9{\%} (339/361). 4. Clinical effects of NFLX classified by diseases with identified pathogens were 81.8{\%} (9/11) for acute pneumonia, 80.8{\%} (21/26) for other respiratory infections, 95.8{\%} (23/24) for bacillary dysentery, 98.6{\%} (70/71) for Campylobacter enteritis, 100{\%} (24/24) for Salmonella enteritis, 100{\%} (6/6) for other acute enteritis and 98.1{\%} (104/106) for urinary tract infections. Including other infections as high as 94.3{\%} (266/282) of efficacy rate was obtained in total. There was no significant difference in NFLX efficacies between unidentified and identified pathogens. Thus, the total clinical efficacy rate was 93.9{\%} (339/361). 5. The total eradication rate of 325 pathogens evaluable was 84.3{\%},with identical eradication rates for Gram-positive cocci (GPC) (43/51) and for Gram-negative rods (GNR) (231/274). 6. The optimal daily dose of NFLX seemed to be in a range between 6.0 and 12.0 mg/kg, and the optimal duration of treatment to be 7 days for children over 5 years old. 7. The clinical efficacy in treating P. aeruginosa infections in 12 patients was 100{\%} (11/11) and the eradication rate was 83.3{\%} (10/12). 8. In 59 non-responsive cases to other antimicrobials (treated over 3 days), efficacy rate was 88.9{\%} with 58.3{\%} of the excellent responder rate. Particularly in 13 cases treated with penicillin of cephems the overall efficacy rate was 90.9{\%}, and the eradication rate was 93.6{\%}. Except 1 strain of Streptococcus pneumoniae in 10 strains of GPC and 2 strains of P. aeruginosa in 37 strains of GNR, all bacteria were eradicated. 9. Adverse reactions were found in 6 (1.5{\%}) cases of 406 patients. The reactions were all mild and could continue the administration of the drug. The joint injuries were not found in all cases nevertheless our careful observation to the joint. Laboratory examinations revealed transient and mild eosinophillia in 8 cases of 309 patients studied. And no changed was observed in serum Cathepsin D, ASPRO-GP, Al-P, urinary mucopolysiaccharide titers and electrophoretic isozyme patterns of Al-P which suggest arthropathy, during the course of NFLX therapy.",
author = "Ryochi Fujii and Hidenori Meguro and Osamu Arimasu and Kouji Ushijima and Toshiaki Abe and Susumu Nakazawa and Hajime Sato and Akira Narita and Kenji Niino and Haruo Ichihashi and Hiroo Matsuda and Hiroshi Hirosawa and Shintaro Takahashi and Yasuko Ishikawa and Yoshikiyo Toyonaga and Morimasa Sugita and Keisuke Sunakawa and Hironobu Akita and Yoshitake Sato and Satoshi Iwata and Mikio Minamitani and Kei Hachimori and Kuniyoshi Kuno and Akimasa Ogawa and Yoshikuni Nakao and Fumio Hayakawa and Yoshihiro Ando and Osamu Kito and Naoichi Iwai and Mitsunobu Miyazu and Haruhi Nakamura and Michihiro Katayama and Keiko Kasai and Minoru Sakurai and Hitoshi Kamiya and Toshiaki Ihara and Hiroshi Kawaguchi and Tadafumi Nishimura and Michio Takagi and Kazuo Tabuki and Shigeyuki Aoki and Yutaka Kobayashi and Tsunekazu Haruta and Hiroshi Matsuda and Kaichi Kida and Junichi Ishikawa and Toshihito Matsuura and Hironao Nagai and Hideo Morita and Takashi Tomoda and Kumiko Araki and Kenji Matsumoto and Noriko Zushi and Takanobu Kurashige and Yohei Nishibayashi and Kaname Okada and Shoji Kagami and Yasuhiro Kuroda and Takashige Okada and Seikyo Furukawa and Takashi Motohiro and Yasutaka Sakata and Masafumi Aramaki and Keiko Oda and Akira Kawakami and Tatsuhiko Koga and Fumio Yamashita and Syunji Karube",
year = "1990",
doi = "10.11553/antibiotics1968b.43.181",
language = "English",
volume = "43",
pages = "181--215",
journal = "The Journal of antibiotics. Ser. B",
issn = "0368-2781",
publisher = "Japan Antibiotics Research Association",
number = "1",

}

TY - JOUR

T1 - Evaluation of Norfloxacin in the Pediatric Field

T2 - Pediatric Study Group for Norfloxacin

AU - Fujii, Ryochi

AU - Meguro, Hidenori

AU - Arimasu, Osamu

AU - Ushijima, Kouji

AU - Abe, Toshiaki

AU - Nakazawa, Susumu

AU - Sato, Hajime

AU - Narita, Akira

AU - Niino, Kenji

AU - Ichihashi, Haruo

AU - Matsuda, Hiroo

AU - Hirosawa, Hiroshi

AU - Takahashi, Shintaro

AU - Ishikawa, Yasuko

AU - Toyonaga, Yoshikiyo

AU - Sugita, Morimasa

AU - Sunakawa, Keisuke

AU - Akita, Hironobu

AU - Sato, Yoshitake

AU - Iwata, Satoshi

AU - Minamitani, Mikio

AU - Hachimori, Kei

AU - Kuno, Kuniyoshi

AU - Ogawa, Akimasa

AU - Nakao, Yoshikuni

AU - Hayakawa, Fumio

AU - Ando, Yoshihiro

AU - Kito, Osamu

AU - Iwai, Naoichi

AU - Miyazu, Mitsunobu

AU - Nakamura, Haruhi

AU - Katayama, Michihiro

AU - Kasai, Keiko

AU - Sakurai, Minoru

AU - Kamiya, Hitoshi

AU - Ihara, Toshiaki

AU - Kawaguchi, Hiroshi

AU - Nishimura, Tadafumi

AU - Takagi, Michio

AU - Tabuki, Kazuo

AU - Aoki, Shigeyuki

AU - Kobayashi, Yutaka

AU - Haruta, Tsunekazu

AU - Matsuda, Hiroshi

AU - Kida, Kaichi

AU - Ishikawa, Junichi

AU - Matsuura, Toshihito

AU - Nagai, Hironao

AU - Morita, Hideo

AU - Tomoda, Takashi

AU - Araki, Kumiko

AU - Matsumoto, Kenji

AU - Zushi, Noriko

AU - Kurashige, Takanobu

AU - Nishibayashi, Yohei

AU - Okada, Kaname

AU - Kagami, Shoji

AU - Kuroda, Yasuhiro

AU - Okada, Takashige

AU - Furukawa, Seikyo

AU - Motohiro, Takashi

AU - Sakata, Yasutaka

AU - Aramaki, Masafumi

AU - Oda, Keiko

AU - Kawakami, Akira

AU - Koga, Tatsuhiko

AU - Yamashita, Fumio

AU - Karube, Syunji

PY - 1990

Y1 - 1990

N2 - Norfloxacin (NFLX, AM-715), a new quinolone antibiotic agent, was evaluated clinically and bacteriologically for its efficacy and safety in pediatrics by a study group organized with pediatricians from all over the country. A summary of the results of the evaluation is as follows. 1. Incidence of NFLX-resistant strains (MIC over 12.5 μg/ml) isolated from children with various infections was 1.6% (8/512). One resistant strain was observed among 45 isolates of Staphylococcus aureus, and none among 30 isolates of Pseudomonas aeruginosa. 2. After single oral administration of 1.5~2.9, 3.0~4.8 and 5.1~6.1 mg/kg NFLX in tablet form at fasting, mean peak values of serum concentration of 0.37, 0.56, 0.92 μg/ml, T 1/2 of 2.5, 2.6, 2.6 hours and urinary recovery rates in 8 hours at 25.3, 25.3, 27.1% were observed, respectively. 3. Clinical effects were studied chiefly in intestinal and urinary tract infections. Among 317 patients from whom pathogens had been isolated, responses to the treatment were excellent in 187, good in 79, fair in 9, poor in 7, and unknown in 35 cases. The overall efficacy rate was 94.3% (266/282) and the efficacy rate for excellent responses was 70.3% (187/266). Among all the 406 patients treated, including those with undetermined pathogens, responses were excellent in 233, good in 106, fair in 11, poor in 11, and unknown in 45 cases. The overall efficacy rate was 93.9% (339/361). 4. Clinical effects of NFLX classified by diseases with identified pathogens were 81.8% (9/11) for acute pneumonia, 80.8% (21/26) for other respiratory infections, 95.8% (23/24) for bacillary dysentery, 98.6% (70/71) for Campylobacter enteritis, 100% (24/24) for Salmonella enteritis, 100% (6/6) for other acute enteritis and 98.1% (104/106) for urinary tract infections. Including other infections as high as 94.3% (266/282) of efficacy rate was obtained in total. There was no significant difference in NFLX efficacies between unidentified and identified pathogens. Thus, the total clinical efficacy rate was 93.9% (339/361). 5. The total eradication rate of 325 pathogens evaluable was 84.3%,with identical eradication rates for Gram-positive cocci (GPC) (43/51) and for Gram-negative rods (GNR) (231/274). 6. The optimal daily dose of NFLX seemed to be in a range between 6.0 and 12.0 mg/kg, and the optimal duration of treatment to be 7 days for children over 5 years old. 7. The clinical efficacy in treating P. aeruginosa infections in 12 patients was 100% (11/11) and the eradication rate was 83.3% (10/12). 8. In 59 non-responsive cases to other antimicrobials (treated over 3 days), efficacy rate was 88.9% with 58.3% of the excellent responder rate. Particularly in 13 cases treated with penicillin of cephems the overall efficacy rate was 90.9%, and the eradication rate was 93.6%. Except 1 strain of Streptococcus pneumoniae in 10 strains of GPC and 2 strains of P. aeruginosa in 37 strains of GNR, all bacteria were eradicated. 9. Adverse reactions were found in 6 (1.5%) cases of 406 patients. The reactions were all mild and could continue the administration of the drug. The joint injuries were not found in all cases nevertheless our careful observation to the joint. Laboratory examinations revealed transient and mild eosinophillia in 8 cases of 309 patients studied. And no changed was observed in serum Cathepsin D, ASPRO-GP, Al-P, urinary mucopolysiaccharide titers and electrophoretic isozyme patterns of Al-P which suggest arthropathy, during the course of NFLX therapy.

AB - Norfloxacin (NFLX, AM-715), a new quinolone antibiotic agent, was evaluated clinically and bacteriologically for its efficacy and safety in pediatrics by a study group organized with pediatricians from all over the country. A summary of the results of the evaluation is as follows. 1. Incidence of NFLX-resistant strains (MIC over 12.5 μg/ml) isolated from children with various infections was 1.6% (8/512). One resistant strain was observed among 45 isolates of Staphylococcus aureus, and none among 30 isolates of Pseudomonas aeruginosa. 2. After single oral administration of 1.5~2.9, 3.0~4.8 and 5.1~6.1 mg/kg NFLX in tablet form at fasting, mean peak values of serum concentration of 0.37, 0.56, 0.92 μg/ml, T 1/2 of 2.5, 2.6, 2.6 hours and urinary recovery rates in 8 hours at 25.3, 25.3, 27.1% were observed, respectively. 3. Clinical effects were studied chiefly in intestinal and urinary tract infections. Among 317 patients from whom pathogens had been isolated, responses to the treatment were excellent in 187, good in 79, fair in 9, poor in 7, and unknown in 35 cases. The overall efficacy rate was 94.3% (266/282) and the efficacy rate for excellent responses was 70.3% (187/266). Among all the 406 patients treated, including those with undetermined pathogens, responses were excellent in 233, good in 106, fair in 11, poor in 11, and unknown in 45 cases. The overall efficacy rate was 93.9% (339/361). 4. Clinical effects of NFLX classified by diseases with identified pathogens were 81.8% (9/11) for acute pneumonia, 80.8% (21/26) for other respiratory infections, 95.8% (23/24) for bacillary dysentery, 98.6% (70/71) for Campylobacter enteritis, 100% (24/24) for Salmonella enteritis, 100% (6/6) for other acute enteritis and 98.1% (104/106) for urinary tract infections. Including other infections as high as 94.3% (266/282) of efficacy rate was obtained in total. There was no significant difference in NFLX efficacies between unidentified and identified pathogens. Thus, the total clinical efficacy rate was 93.9% (339/361). 5. The total eradication rate of 325 pathogens evaluable was 84.3%,with identical eradication rates for Gram-positive cocci (GPC) (43/51) and for Gram-negative rods (GNR) (231/274). 6. The optimal daily dose of NFLX seemed to be in a range between 6.0 and 12.0 mg/kg, and the optimal duration of treatment to be 7 days for children over 5 years old. 7. The clinical efficacy in treating P. aeruginosa infections in 12 patients was 100% (11/11) and the eradication rate was 83.3% (10/12). 8. In 59 non-responsive cases to other antimicrobials (treated over 3 days), efficacy rate was 88.9% with 58.3% of the excellent responder rate. Particularly in 13 cases treated with penicillin of cephems the overall efficacy rate was 90.9%, and the eradication rate was 93.6%. Except 1 strain of Streptococcus pneumoniae in 10 strains of GPC and 2 strains of P. aeruginosa in 37 strains of GNR, all bacteria were eradicated. 9. Adverse reactions were found in 6 (1.5%) cases of 406 patients. The reactions were all mild and could continue the administration of the drug. The joint injuries were not found in all cases nevertheless our careful observation to the joint. Laboratory examinations revealed transient and mild eosinophillia in 8 cases of 309 patients studied. And no changed was observed in serum Cathepsin D, ASPRO-GP, Al-P, urinary mucopolysiaccharide titers and electrophoretic isozyme patterns of Al-P which suggest arthropathy, during the course of NFLX therapy.

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JO - The Journal of antibiotics. Ser. B

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